BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 5004786 · Received August 14, 2015

    Report

    Report Number
    3011393376-2015-02646
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 25, 2015
    Report Date
    September 21, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    KZH
    PMA / PMN Number
    K063146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    LINK ASSIST DEVICE IS NOT CONSISTENTLY RELEASING HEADSET WHEN CUSTOMER PRESSES THE RELEASE BUTTON. THEN, WHEN CUSTOMER SLIDES THE GREY PORTION BACK INTO THE BLUE BASE OF DEVICE, IT UNINTENTIONALLY RELEASES THE HEADSET. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540549 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1